DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE - Generic Drug Details

What are the generic sources for dapagliflozin; metformin hydrochloride and what is the scope of freedom to operate?

Dapagliflozin; metformin hydrochloride is the generic ingredient in two branded drugs marketed by Astrazeneca Ab and is included in two NDAs. There are eleven patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Dapagliflozin; metformin hydrochloride has two hundred and thirty-six patent family members in forty-six countries.

Two suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE

International Patents:	236
US Patents:	11
Tradenames:	2
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	2
Clinical Trials:	102
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE
DailyMed Link:	DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE

Dosage:

TABLET, EXTENDED RELEASE;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Eli Lilly and Company	Phase 3
Institute of Liver and Biliary Sciences, India	N/A
Ain Shams University	Phase 1/Phase 2

See all DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE clinical trials

Generic filers with tentative approvals for DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE

Applicant	Application No.	Strength	Dosage Form
		2.5MG;1GM	TABLET, EXTENDED RELEASE;ORAL
		10MG;1GM	TABLET, EXTENDED RELEASE;ORAL
		10MG;500MG	TABLET, EXTENDED RELEASE;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE

Drug Class	Biguanide Sodium-Glucose Cotransporter 2 Inhibitor
Mechanism of Action	Sodium-Glucose Transporter 2 Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE

A10BA	Biguanides
A10B	BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS
A10	DRUGS USED IN DIABETES
A	Alimentary tract and metabolism

A10BK	Sodium-glucose co-transporter 2 (SGLT2) inhibitors
A10B	BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS
A10	DRUGS USED IN DIABETES
A	Alimentary tract and metabolism

Paragraph IV (Patent) Challenges for DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
XIGDUO XR	Extended-release Tablets	dapagliflozin; metformin hydrochloride	2.5 mg/1000 mg	205649	1	2018-10-29
XIGDUO XR	Extended-release Tablets	dapagliflozin; metformin hydrochloride	5 mg/500 mg 5 mg/1000 mg 10 mg/500 mg 10 mg/1000 mg	205649	10	2018-01-08

US Patents and Regulatory Information for DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Astrazeneca Ab	XIGDUO XR	dapagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205649-001	Oct 29, 2014		RX	Yes	No					Y
Astrazeneca Ab	XIGDUO XR	dapagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205649-002	Oct 29, 2014		RX	Yes	No
Astrazeneca Ab	XIGDUO XR	dapagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205649-005	Jul 28, 2017		RX	Yes	No					Y
Astrazeneca Ab	XIGDUO XR	dapagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205649-001	Oct 29, 2014		RX	Yes	No

Expired US Patents for DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Astrazeneca Ab	XIGDUO XR	dapagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205649-001	Oct 29, 2014
Astrazeneca Ab	XIGDUO XR	dapagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205649-002	Oct 29, 2014
Astrazeneca Ab	XIGDUO XR	dapagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205649-001	Oct 29, 2014
Astrazeneca Ab	XIGDUO XR	dapagliflozin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205649-002	Oct 29, 2014

International Patents for DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE

Country	Patent Number	Title	Estimated Expiration
New Zealand	574346	CRYSTALLINE SOLVATES AND COMPLEXES OF (IS) -1, 5-ANHYDRO-L-C- (3- ( (PHENYL) METHYL) PHENYL) -D-GLUCITOL DERIVATIVES WITH AMINO ACIDS AS SGLT2 INHIBITORS FOR THE TREATMENT OF DIABETES
World Intellectual Property Organization (WIPO)	2011060256
Canada	2780939	FORMULATIONS DE COMPRIME BICOUCHE (BILAYER TABLET FORMULATIONS)
Brazil	PI0311323	composto inibidor de c-aril glicosídeo sglt2, composição farmacêutica e combinação

Supplementary Protection Certificates for DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1506211	PA2014026	Lithuania		PRODUCT NAME: DAPAGLIFOZINUM + METFORMINUM; REGISTRATION NO/DATE: EU/1/13/900 20140116
1506211	PA 2013 008, C 1506211	Lithuania		PRODUCT NAME: DAPAGLIFLOZINUM; REGISTRATION NO/DATE: EU/1/12/795/001 - EU/1/12/795/010 20121112
1506211	C20130006 00074	Estonia		PRODUCT NAME: DAPAGLIFLOZIN;REG NO/DATE: K(2012)8378 12.11.2012
1506211	179 5017-2014	Slovakia		PRODUCT NAME: KOMBINACIA DAPAGLIFLOZINU ALEBO JEHO FARMACEUTICKY PRIJATELNYCH SOLI A METFORMINU ALEBO JEHO FARMACEUTICKY PRIJATELNYCH SOLI; REGISTRATION NO/DATE: EU/1/13/900/001 - EU/1/13/900/012 20140116

DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Dapagliflozin and Metformin Hydrochloride

Introduction

The pharmaceutical market for diabetes treatments is rapidly evolving, driven by increasing cases of diabetes, advancements in medical technology, and changing patient needs. Two key drugs in this landscape are dapagliflozin and metformin hydrochloride. This article delves into the market dynamics and financial trajectory of these medications, highlighting their current status, future prospects, and the factors influencing their market performance.

Increasing Prevalence of Diabetes

The global rise in diabetes cases is a significant driver for the market growth of both dapagliflozin and metformin hydrochloride. The increasing prevalence of type 2 diabetes, fueled by unhealthy lifestyles, genetic mutations, and an aging population, creates a substantial demand for effective diabetes treatments[1].

Market Drivers for Dapagliflozin

Cost-Effectiveness

Dapagliflozin, an SGLT2 inhibitor, has been shown to be cost-effective compared to other glucose-lowering therapies. Studies have indicated that dapagliflozin is cost-saving when compared to GLP-1RAs and DPP-4is, and cost-effective compared to SUs and TZDs in the US setting over a one-year period. This cost-effectiveness is a major driver for its adoption[2].

Clinical Benefits

Dapagliflozin offers several clinical benefits, including improved glycemic control, weight loss, and reduced systolic blood pressure. These benefits contribute to its attractiveness as a treatment option for type 2 diabetes patients[2].

Regulatory Approvals

Dapagliflozin, often combined with metformin in formulations like Xigduo, has received regulatory approvals in various regions, including the European Union. This combination is indicated for adults with type 2 diabetes as an adjunct to diet and exercise to improve glycemic control[5].

Market Drivers for Metformin Hydrochloride

Established Market Presence

Metformin hydrochloride is a well-established first-line treatment for type 2 diabetes. Its long history of use and widespread acceptance make it a staple in diabetes management. The increase in diabetes awareness campaigns and government funding for diabetes treatment further boost its market[1].

High Demand

The lifelong need for diabetes treatment and the growing number of diabetic patients globally drive the demand for metformin hydrochloride. Additionally, the rise in healthcare expenditures and the dependency on metformin hydrochloride for managing type 2 diabetes contribute to its market growth[1].

Market Trends

New Product Launches

The market for both dapagliflozin and metformin hydrochloride is influenced by new product launches and the development of novel diabetes drugs. These innovations often lead to improved treatment outcomes and increased patient compliance, thereby driving market growth[1].

Combination Therapies

The trend towards combination therapies, such as dapagliflozin plus metformin, is gaining traction. These combinations offer enhanced efficacy and better patient outcomes, which in turn drive market demand[5].

Financial Trajectory

Cost-Effectiveness Analysis

Studies have shown that dapagliflozin, despite being more expensive than metformin in some contexts, offers long-term cost-effectiveness. For instance, in China, dapagliflozin treatment was found to be more cost-effective than metformin, with an incremental cost-effectiveness ratio of 10,729 yuan per QALY gained[3].

Market Size and Growth

The metformin hydrochloride market is expected to grow significantly due to the increasing cases of diabetes and the rising demand for type 2 diabetes treatments. The COVID-19 pandemic has also accelerated the growth of the pharmaceutical industry, including the market for diabetes medications, due to increased healthcare expenditures and the need for effective treatments[1].

Challenges and Restraints

Side Effects and Substitutes

Both dapagliflozin and metformin hydrochloride face challenges related to side effects. For example, metformin hydrochloride can lead to gastrointestinal symptoms and rare cases of vitamin B12 deficiency. Dapagliflozin is associated with increased blood creatinine, urinary tract infections, and hypovolaemia. The availability of substitutes, such as homeopathic treatments, also poses a restraint to market growth[1][5].

Opportunities in Emerging Markets

Emerging markets present significant opportunities for the expansion of both dapagliflozin and metformin hydrochloride. The growing healthcare infrastructure and increasing awareness of diabetes in these regions are expected to drive market growth in the future[1].

Competitive Landscape

The competitive landscape for these drugs is intense, with several pharmaceutical companies investing in R&D to improve the quality and efficacy of diabetes treatments. Porter’s five forces analysis highlights the potency of buyers and suppliers in the market, indicating a competitive environment where companies must innovate to stay ahead[1].

Regulatory and Safety Profile

Regulatory approvals and a favorable safety profile are crucial for the market success of these drugs. Dapagliflozin, for instance, has shown a similar incidence of adverse events compared to placebo in clinical trials, making it a safe option for patients[5].

Conclusion

The market dynamics for dapagliflozin and metformin hydrochloride are driven by a combination of factors including increasing diabetes prevalence, cost-effectiveness, clinical benefits, and regulatory approvals. While challenges such as side effects and substitutes exist, the overall financial trajectory for these drugs is positive, with significant growth opportunities in emerging markets.

Key Takeaways

• Increasing diabetes prevalence drives demand for both dapagliflozin and metformin hydrochloride.
• Dapagliflozin is cost-effective compared to other glucose-lowering therapies.
• Combination therapies like dapagliflozin plus metformin are gaining traction.
• Emerging markets offer significant growth opportunities.
• Side effects and substitutes are key restraints to market growth.

FAQs

Q: What are the primary drivers for the growth of the metformin hydrochloride market? A: The primary drivers include the increase in cases of diabetes, adaptation of unhealthy lifestyles, rise in population suffering from malnutrition and genetic mutations, and increased healthcare expenditures[1].

Q: How does dapagliflozin compare to other glucose-lowering therapies in terms of cost-effectiveness? A: Dapagliflozin is cost-saving compared to GLP-1RAs and DPP-4is, and cost-effective compared to SUs and TZDs over a one-year period in the US setting[2].

Q: What are the common side effects associated with dapagliflozin? A: Common side effects include increased blood creatinine, urinary tract infections, hypovolaemia, and hypotension[5].

Q: How does the combination of dapagliflozin and metformin benefit patients? A: The combination offers improved glycemic control, weight loss, and reduced systolic blood pressure, making it an effective treatment option for type 2 diabetes patients[5].

Q: What role do emerging markets play in the growth of the dapagliflozin and metformin hydrochloride markets? A: Emerging markets present significant opportunities due to growing healthcare infrastructure and increasing awareness of diabetes, driving future market growth[1].

Sources

1. Allied Market Research: Metformin Hydrochloride Market Size | Industry Growth By, (2021)
2. PubMed: Comparison of costs and outcomes of dapagliflozin with other treatments for type 2 diabetes
3. PubMed: Cost-effectiveness analysis of dapagliflozin treatment versus metformin treatment in China
4. Archivepp: RP-HPLC Method for Dapagliflozin and Metformin HCL in Bulk and Combined Formulation
5. European Union: Xigduo, INN-dapagliflozin/metformin